Adaptor

ABSTRACT

An apparatus and method of electrically coupling a previously implanted stimulation lead with a replacement neurostimulator device. The apparatus and method configured to operably couple a proximal portion of a neuromodulation adaptor including a plurality of electrical conductors spaced apart at a first pitch spacing to a corresponding plurality of electrical terminals of a replacement neurostimulator device, and operably couple a distal end of the neuromodulation adaptor including a plurality of conductor elements and an electrically active set screw spaced part of a second pitch spacing to a corresponding plurality of electrical connectors of a previously implanted stimulation lead.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 62/950,663, filed Dec. 19, 2019, U.S. ProvisionalApplication No. 62/950,665, filed Dec. 19, 2019, U.S. ProvisionalApplication No. 62/915,887, filed Oct. 16, 2019, and U.S. ProvisionalApplication No. 62/910,566, filed Oct. 4, 2019, the disclosures of whichare hereby incorporated by reference in their entireties.

FIELD

The present technology is generally related to methods, systems anddevices related to electrical stimulation therapy.

BACKGROUND

A number of human bodily functions are affected by the nervous system.For example, bodily disorders, such as urinary incontinence, urinaryurge/frequency, urinary retention, pelvic pain, bowel dysfunction(constipation, diarrhea, etc.), erectile dysfunction, etc. are allbodily functions influenced by the sacral nerves. One technique to treatsuch bodily disorders is sacral nerve stimulation therapy. Sacral nervestimulation therapy is a treatment that uses a small device to send mildelectrical impulses to nerves located in the lower region of the spine(just above the tailbone). These nerves, referred to as sacral nerves(specifically S2, S3 and S4), influence the behavior of structures suchas the bladder, sphincter and pelvic floor muscles. In some cases,electrical stimulation of the sacral nerves can successfully eliminateor reduce the above mentioned bodily disorders.

Generally, implantation of a sacral neuromodulation system involvessurgically implanting a stimulation lead near the sacral nerves. Thestimulation lead is a small, insulated, electrical conductor withstimulation electrodes on the distal end for implementation near thesacral nerves, and an electrical connector on the proximal end of thelead. The proximal end electrical connector is typically connected to animplantable neurostimulator device that operates in a fashion broadlysimilar to that of a cardiac pacemaker by delivering occasional mildelectrical pulses to the sacral nerve of the patient.

The power used to generate the mild electrical pulses typicallyoriginates from a primary cell or battery located in the implantableneurostimulator device. Over an extended period of use, the battery canbecome depleted. For example, some currently available implantableneurostimulator devices may have a battery lifetime about ten years orless. Once the battery is depleted, it is common for patients to havethe neurostimulator device replaced.

The emergence of implantable neurostimulator devices with rechargeablebatteries has reduced the form factor of such devices. A rechargeablebattery may be configured to last only a period of weeks betweencharges, and thus may be physically smaller in size than a batteryintended to last years. As a result of this reduced size, the design ofthe stimulation leads compatible with newer devices has also changed. Inparticular, the size or configuration of the electrical connector on theproximal end of the lead has been reduced in size for improved matingwith the smaller neurostimulator devices. As a result, some legacy andcurrent stimulation leads may not be compatible with emerging and/ornext-generation neuromodulation devices.

By contrast to the neurostimulator device, the stimulation leadstypically have a much longer usable lifetime than the neurostimulatordevice. Further, replacement of the stimulation lead is typicallyconsidered a more invasive procedure, as unlike the neurostimulatordevice which is generally located just beneath the skin of the patient,the stimulation leads extend much further into the patient and areconsidered to be more challenging to place correctly. Additionally, manyleads include one or more tines or barbs positioned on the distal end ofthe lead, which serve to anchor the lead in place within the patient astissue fills in around the lead over time. Accordingly, it is generallyconsidered preferable to leave the stimulation lead in place when theneurostimulator device is replaced. Unfortunately, not all stimulationleads are compatible with all neurostimulator devices. The presentdisclosure addresses this concern.

SUMMARY

The techniques of this disclosure generally relate to a neuromodulationadaptor configured to enable an electrically compatible connectionbetween otherwise incompatible leads and neurostimulation devices, forexample between a previously implanted stimulation lead and areplacement neurostimulator device, so as to increase physician orpatient options in replacing components of a neuromodulation system. Anumber of factors may cause incompatibility between an implantablestimulation lead and a neurostimulator device, such as variation in thenumber of electrodes (e.g., one, two, four, etc.) included on the lead,the spacing of electrical contacts on the lead in the region where thelead is connected to the neurostimulator device, diameter of the lead,and use of active or inactive set screws, for example.

The present disclosure provides neuromodulation adaptor embodiments,including a proximal portion and a distal portion. The proximal portioncan include a plurality of electrical conductors spaced apart at a firstpitch spacing and configured to electrically engage with thecorresponding plurality of electrical terminals of a neurostimulatordevice. The distal portion can include a plurality of conductor elementsand a set screw, the plurality of conductor elements and set screw canbe spaced apart at a second pitch spacing and can be configured toelectrically engage with a corresponding plurality of electricalconnectors of a stimulation lead. The first pitch spacing can have apitch spacing of at least one of about 0.170 inches, about 0.085 inchesor about 2 millimeters (about 0.080 inches), while the second pitchspacing can have a pitch spacing of about 0.170 inches, about 0.085inches or about 2 millimeters (about 0.080 inches), wherein the firstpitch spacing is different from the second pitch spacing, therebyenabling an electrical coupling between an otherwise incompatiblestimulation lead and a replacement neurostimulator device.

In some embodiments, the proximal portion of the neuromodulation adaptorcan include a forward stop configured to serve as a reference point forspacing of the plurality of electrical conductors relative to acorresponding plurality of electrical terminals of a neurostimulatordevice. In some embodiments, the distal portion can include a datumreference configured to serve as a reference point for spacing of theplurality of conductor elements relative to a corresponding plurality ofelectrical connectors of a stimulation lead. In some embodiments, theneuromodulation adaptor can further include a flexible portion locatedbetween the proximal portion and the distal portion, configured toenable bending of the neuromodulation adaptor to aid in an idealpositioning of a neurostimulator device relative to a stimulation leadwithin a body of a patient. In some embodiments, the neuromodulationadaptor can further include a septum configured to provide a fluidresistant seal to inhibit contact between an electrically active setscrew and a bodily fluid.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description in the drawings, and from theclaims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic view depicting an implanted neuromodulation systemadapted for sacral nerve stimulation, in accordance with the prior art.

FIG. 2 is a schematic view depicting a stimulation lead implanted near asacral nerve for stimulation, in accordance with the prior art.

FIG. 3A is a cross-sectional profile view depicting a proximal portionof a stimulation lead and a neurostimulator device, in accordance with afirst embodiment of the disclosure.

FIG. 3B is a cross-sectional profile view depicting a proximal portionof a stimulation lead and a neurostimulator device, in accordance with asecond embodiment of the disclosure.

FIG. 3C is a cross-sectional profile view depicting a proximal portionof a stimulation lead and a neurostimulator device, in accordance with athird embodiment of the disclosure.

FIG. 4 is a schematic view depicting an implanted neuromodulation systemadapted for sacral nerve stimulation, in accordance with the disclosure.

FIG. 5A is an assembly view depicting a previously implantedneurostimulator device and stimulation lead, in accordance with theprior art.

FIG. 5B is an assembly view depicting an adapted neuromodulation system,including a replacement neurostimulator device, previously implantedstimulation lead, and adaptor electrically coupling the otherwiseincompatible stimulation lead and replacement neurostimulator device, inaccordance with a first embodiment of the disclosure.

FIG. 6 is a cross-sectional, profile view depicting an adaptor, inaccordance with a first embodiment of the disclosure.

FIG. 7A is a perspective view depicting an adaptor, in accordance with asecond embodiment of the disclosure.

FIG. 7B is a cross-sectional, profile view depicting the adaptor of FIG.7A.

FIG. 8 is a profile view depicting an adaptor, in accordance with athird embodiment of a disclosure.

FIG. 9 is a profile view depicting an adaptor, in accordance with afourth embodiment of a disclosure.

FIG. 10 is a profile view depicting an adaptor, in accordance with afifth embodiment of a disclosure.

FIG. 11A is an assembly view depicting a previously implantedneurostimulator device and stimulation lead, in accordance with theprior art.

FIG. 11B is an assembly view depicting an adapted neuromodulationsystem, including a replacement neurostimulator device, previouslyimplanted stimulation lead, and adaptor electrically coupling theotherwise incompatible stimulation lead and replacement neurostimulatordevice, in accordance with a second embodiment of the disclosure.

FIG. 12A is a cross-sectional, profile view depicting an adaptor, inaccordance with a sixth embodiment of the disclosure.

FIG. 12B is a close-up, partial cross-sectional view depicting aproximal portion of the adaptor of FIG. 12A.

FIG. 12B is a close-up, partial cross-sectional view depicting a distalportion of the adaptor of FIG. 12A.

FIG. 13 is a perspective view depicting an adaptor, in accordance with aseventh embodiment of the disclosure.

FIG. 14A is an assembly view depicting a previously implantedneurostimulator device and stimulation lead, in accordance with theprior art.

FIG. 14B is an assembly view depicting an adapted neuromodulationsystem, including a replacement neurostimulator device, previouslyimplanted stimulation lead, and adaptor electrically coupling theotherwise incompatible stimulation lead and replacement neurostimulatordevice, in accordance with a third embodiment of the disclosure.

FIG. 15A is an assembly view depicting a previously implantedneurostimulator device and stimulation lead, in accordance with theprior art.

FIG. 15B is an assembly view depicting an adapted neuromodulationsystem, including a replacement neurostimulator device, previouslyimplanted stimulation lead, and adaptor electrically coupling theotherwise incompatible stimulation lead and replacement neurostimulatordevice, in accordance with a fourth embodiment of the disclosure.

FIG. 16A is an assembly view depicting a previously implantedneurostimulator device and stimulation lead, in accordance with theprior art.

FIG. 16B is an assembly view depicting an adapted neuromodulationsystem, including a replacement neurostimulator device, previouslyimplanted stimulation lead, and adaptor electrically coupling theotherwise incompatible stimulation lead and replacement neurostimulatordevice, in accordance with a fifth embodiment of the disclosure.

FIG. 17A is an assembly view depicting a previously implantedneurostimulator device and stimulation lead, in accordance with theprior art.

FIG. 17B is an assembly view depicting an adapted neuromodulationsystem, including a replacement neurostimulator device, previouslyimplanted stimulation lead, and adaptor electrically coupling theotherwise incompatible stimulation lead and replacement neurostimulatordevice, in accordance with a sixth embodiment of the disclosure.

While embodiments of the disclosure are amenable to variousmodifications and alternative forms, specifics thereof shown by way ofexample in the drawings will be described in detail. It should beunderstood, however, that the intention is not to limit the disclosureto the particular embodiments described. On the contrary, the intentionis to cover all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the subject matter as defined by theclaims.

DETAILED DESCRIPTION

FIG. 1 schematically illustrates an example of an implementedneuromodulation system 100 adapted for sacral nerve stimulation.Neuromodulation system 100 includes a neurostimulator device 102implanted in a lower buttock region of a patient, connected to animplanted stimulation lead 104 extending through a foramen forstimulation of a sacral nerve. As depicted in FIG. 1, the stimulationlead 104 is oriented through the S3 foramen, although other locationssuch as S2 or S4 are also contemplated. The stimulation lead 104 caninclude a distal portion 108 including one or more stimulationelectrodes 110 configured to transmit electrical pulses to a nerve,nerve tissue, or other target site within a patient. In one embodiment,the stimulation electrodes 110 can be configured as an array of two,three, four or more ring-shaped electrodes for delivering electricalstimulation. In other embodiments, the stimulation lead 104 can includea greater or lesser number of electrodes. The proximal portion 114 ofthe stimulation lead 104 is plugged into the neurostimulator device 102,for example via a header of device 102.

The stimulation lead 104 is anchored by a tined anchor portion 112 thatmaintains a position of a set of stimulation electrodes 110 along orotherwise proximate a targeted nerve. Over time, tissue surrounding thestimulation lead 104 can grow between the tines 112, thereby aiding insecuring the stimulation lead 104 in a fixed position relative to thenerve or other target site within a patient. The stimulation lead canhave a variety of shapes, can be a variety of sizes, and can be made ofa variety of materials, which size, shape, and materials can be tailoredto the specific treatment application. The electrical pulses generatedby the neuromodulation system 100 are delivered to one or more targetedsacral nerves via one or more stimulation electrode 110 at or near thedistal portion 108 of the stimulation lead 104.

The pulsed electrical stimulation may be to one of several nerves;however for purposes of describing the system 100, the stimulation siteis referred to herein simply as “sacral nerves.” It should be understoodthat the term “sacral nerves” as used herein includes sacral nerves S1,S2, S3, S4, as well as other nerve sites such as pudendal nerve,superior gluteal nerve, lumbo-sacral trunk, inferior gluteal nerve,common fibular nerve, tibial nerve, posterior femoral cutaneous nerve,sciatic nerve, and obturator nerve. Additionally, stimulation may beprovided unilaterally or bilaterally via two leads.

While this embodiment is adapted for sacral nerve stimulation, it isappreciated that similar systems can be used to provide therapy forurinary incontinence, urological disorders and or fecal incontinence.The urological disorders include overflow incontinence, stressincontinence, overactive bladder (OAB), idiopathic chronic urinaryretention, interstitial cystitis, neural urological disorder,vescico-urethral dysfunctions, bladder inflammation, bladder pain,pelvic pain, genito-urinary disorders, such as prostatitis, prostatagia,and prostatodynia. Electrical stimulation is typically delivered to thesacral nerve root S3, but may be delivered to the S2, S4 or other sacralnerves or branches such as the pudendal nerves or perineal nerves. Inother applications, the stimulation leads 104 may be, for example,implemented in a peripheral portion of a patient's body, such as in thearms or legs, and can be configured to deliver electrical pulses to theperipheral nerve, such as may be used to relieve chronic pain.Stimulation may be applied in bipolar mode, or in unipolar mode wherethe neurostimulator device 102 is used as an anode. It is appreciatedthat the stimulation leads 104 and/or the stimulation programs may varyaccording to the nerves being targeted.

FIG. 2 depicts an overall schematic of the sacral nerve area with thestimulation lead 104 implanted near a sacral nerve for stimulation. Thestimulation lead 104 is inserted by first making an incision appropriateto the size of the patient and then splitting the paraspinal musclefibers to expose the sacral foramen. A physician then locates thedesired position and inserts the stimulation lead into the foramen andanchors the stimulation lead 104 in place. The stimulation lead 104should be placed close enough to the nerve bundles such that theelectrical stimulation results in a desired physiological response. Thedesired physiological response varies depending on which pelvic floordisorder is being treated or which nerve is being stimulated. Thepreferred position for the implantable lead 104 is implementation inclose proximity to the nerve; as such placement results in the mostefficient transfer of electrical energy.

To determine the best location of the stimulation lead 104, an insulatedneedle with both ends exposed for electrical stimulation is often usedto locate the foramen and locate the proximity of the nerve byelectrically stimulating the needle using an external pulse generator.The location is tested by evaluating the physiologic response and by theelectrical threshold required to get that response. Once the appropriatelocation has been determined using the insulated needle, the stimulationlead 104 is implanted in that approximate location. In some embodiments,the stimulation lead 104 is advanced through the foramen until theelectrodes 110 are positioned at the anterior sacral nerve root, whilethe anchoring portion 112 of the lead 104 proximal to the stimulationelectrodes 110 are generally positioned dorsal of the sacral foramenthrough which the lead 104 passes, so as to anchor the lead 104 inposition. A proximal portion 114 of the stimulation lead 104 is tunneledsubcutaneously to a site where the neurostimulator device 102 isimplanted, which is usually in the lower abdominal area (or may be inthe gluteal region). The neurostimulator device 102 is connected to theproximal portion 114 of the stimulation lead 104, placed in asubcutaneous pocket, and the tissues are surgically closed in layers.Stimulation therapy can be applied after the tissues are healed from thesurgery.

The neurostimulator device 102 may be explanted and replaced if needed,with relative ease. Reasons for replacing neurostimulator device 102 mayinclude battery depletion, malfunctioning of the device, or desire toupgrade to a newer generation device. In contrast, replacement of astimulation lead 104 after initial implant is typically undesirable.This is due, in part, because tissue surrounding the stimulation lead104 typically grows between the tines 112 such that removal of thestimulation lead 104 may cause trauma to the surrounding tissue.Additionally, if a previously implanted stimulation lead 104 wasproperly positioned to deliver effective therapy to the patient, asurgeon is unlikely to replace the existing lead, avoiding the need toreevaluate positioning of a replacement lead for a proper physiologicalresponse with an insulated needle and external pulse generator, asdescribed above. Accordingly, unless it is determined that thestimulation lead 104 is not functioning properly or is damaged, it ispreferable to reuse a previously implanted stimulation lead 104 shouldthe neurostimulator device 102 require replacement.

With additional reference to FIGS. 3A-C, the proximal portion 114 of thestimulation lead 104 can include one or more electrical connectors 116configured to be operably coupled to a neurostimulator device 102 oradaptor 106 (alternatively referred to herein as an “adapter”). Asdepicted, the proximal portion 114 can include an array of fourinsulated ring-shaped connectors; although a greater or lesser number ofconnectors is also contemplated.

As depicted, the connectors 116 can be separated or spaced apart fromone another at a fixed distance D, alternatively referred to as “pitchspacing” or “pitch.” For example, in one embodiment, the plurality ofconnectors 116A-D can be spaced apart from one another at a pitch ofapproximately 0.170 inches (as depicted in FIG. 3A). In anotherembodiment, the plurality of connectors 116A-D can be spaced apart fromone another at a pitch of approximately 0.085 inches (as depicted inFIG. 3B). In yet another embodiment, the plurality of connectors 116A-Dcan be spaced apart from one another at a pitch of approximately 2 mm(as depicted in FIG. 3C). Other pitch configurations are alsocontemplated. In addition to varying pitch configurations, stimulationleads 104 can differ in their outer diameter dimensions, general shape(e.g., blunt, tapered or rounded proximal end 115), as well as otherphysical characteristics.

In some embodiments, the proximal portion 114 can include a datumreference 117 configured to serve as a reference point for the spacingof the various connectors 116 or configured to serve as a physical stopwhen inserting the lead into a neurostimulator. For example, in oneembodiment, the datum reference 117 can be located on the proximal end115 of the stimulation electrode 110 (as depicted in FIGS. 3A and 3B),such that insertion of the lead 104 into the neurostimulator deviceuntil the datum reference 117 (e.g., proximal end 115) contacts aforward stop 119 thereby aligns the connections 116A-D of lead 104 withcorresponding connector elements 138A-D of a header 103 of theneurostimulator device 102 and/or adapter 106. In another embodiment,the datum reference 117 can be located distally from the connectors116A-D (as depicted in FIG. 3C), such that insertion of the lead 104into the header 103 until the datum reference 117 contacts an abuttingsurface 121 thereby aligns the connectors 116A-D of lead 104 withcorresponding connector elements 138A-D of the header 103 and/or adapter106.

In some embodiments, the neurostimulator device 102 and/or adapter 106can include a set screw 132 configured to tighten against the proximalportion 114, thereby enabling the proximal portion 114 of thestimulation lead 104 to be secured in position relative to theneurostimulator device 102 and/or adapter 106. In some embodiments, theset screw 132 can be configured to contact at least one of theconnectors 116D (as depicted in FIG. 3A), so as to be electricallyactive. In other embodiments, (as depicted in FIG. 3C) the set screw 132can be electrically inactive, in that it does not contact any of theconnectors 116A-D, but may rather contact another portion of thestimulation lead, such as the datum reference 117.

With reference to FIGS. 4 and 5A-B, in some cases it may be desireableto replace a previously implanted neurostimulator device 101 with areplacement device 102, particularly where the previously implanteddevice has reached or is nearing the end of its serviceable life (e.g.,the previously implanted neurostimulator device may have a primary cellor battery that is near exhaustion), or is otherwise not functioning asdesired. In such cases, the replacement device 102 may be more compactand/or have a different shape than the previously implanted device. Forexample, FIG. 4 depicts an outline of an Interstim II sacralneuromodulation neurostimulator device 101 (manufactured and sold byMedtronic), into which a replacement neurostimulator device 102 can bepositioned. Accordingly, a replacement neurostimulator device 102 candiffer both in shape and size from the previously implanted device 101.For example, the previously implanted device 101 can be a “largeneuromodulation device,” having a volume of at least 10 cubiccentimeters (e.g. the Interstim II device, having a volume of about 14cc), while the replacement neurostimulator device 102 can be a “smallneuromodulation device,” having a volume of about 10 cc or less or about5 cc or less (e.g., the Axonics r-SNM from Axonics ModulationTechnologies having a volume of about 5 cc, or the Medtronic InterstimMicro device, having a volume of about 3.5 cc). Alternatively, thepreviously implanted device 101 can be a small neuromodulation device,and the replacement neurostimulator device 102 can be a largeneuromodulation device. The stated volumes of such devices generallyrefer to the implantable medical device only, and do not include anyassociated leads or adapters which may be coupled to such devices.

Other differences may include the orientation or angle at which thestimulation lead extend from the devices 101, 102, as well as theconnector 116 pitch spacing of the stimulation leads designed to be usedwith the different devices 101, 102. For example, a previously implantedstimulation lead may have an electrical connector with a pitch spacingof about 0.170 inches, while the replacement neurostimulator device 102may be configured to receive a stimulation lead having connectors 116with a pitch spacing of about 0.085 inches or about 2 mm (about 0.080inches). Accordingly, without modification, such as an adapter 106, areplacement device 102 may be incompatible with a previously implantedstimulation lead 104.

FIG. 5A depicts a previously implanted neurostimulator device 101 andstimulation lead 104, wherein the proximal portion 114 of thestimulation lead 104 includes connectors 116 having a pitch spacing ofabout 0.170 inches. FIG. 5B depicts a replacement neurostimulator device102 configured to mate with a stimulation lead having a pitch spacing ofabout 0.085 inches. As further depicted in FIG. 5B, an adapter 106 canbe used to connect the stimulation lead 104 to the replacement device102, thereby providing an electrical coupling between an otherwiseincompatible stimulation lead 104 and neurostimulator device 102.

With additional reference to FIG. 6, in one embodiment, the adapter 106can include a proximal portion 148 configured to be received within astimulation lead port of a neurostimulator device 102, and a distalportion 150 configured to receive a proximal portion of a stimulationlead 104. In one embodiment, the adapter 106 can include a plurality ofconnector elements 154A-D, a set screw block 156, a set screw 158, aboot 162, and a plurality of electrical conductors 164A-D.

In one embodiment, the connector elements 154A-C can form completecircular structures, examples of which include Bal Seal® canted coilconnectors. The connector elements 154A-C can be separated from oneanother by insulative spacers 170A-E, such that the connector elements154A-C and insulative spacers 170A-E are interleaved along alongitudinal axis of the distal portion 150. The insulative seals 170A-Ecan provide wiper seals, and can be constructed of a biocompatiblecompliant material such as silicone. In some embodiments, the insulativeseals 170A-E can be compressible to some degree along the longitudinalaxis, so as to create a tight fit between adjacent connector elements154.

In one embodiment, the set screw block 156 can be configured to enablethreaded insertion of the set screw 158 into the set screw block 156. Insome embodiments, the set screw block 156 can be axially aligned withthe connector elements 154A-C, such that the electrically active setscrew 158 contacts an electrical connector of a stimulation lead 104inserted into the distal portion 150 of the adapter 106. In otherembodiments, the set screw 158 can be electrically inactive.

Although the adapter 106 is depicted as having four connector elements154A-C and an electrically inactive set screw 158, and five insulativeseals 170A-E, other quantities of connector elements 154 and insulativeseals 170 are also contemplated. For example, in one embodiment, theadapter 106 can include three connector elements 154 and an active setscrew block 156, or four connector elements 154. Where a set screw 158is present, the set screw 158 can be configured to tighten against aportion of a stimulation lead 104 received within the distal portion 150of the adapter 106, thereby enabling the stimulation lead 104 to besecured in position relative to the adapter 106. In some embodiments,the set screw block 156 and/or the rear seal 160 can define a forwardstop 178 and/or abutting surface 180 configured to interact with a datumreference 117 of the stimulation lead 104, to ensure that the electricalconnectors of the stimulation lead 104 are appropriately positioned withrespect to the connector elements 154 and/or set screw 158.

During assembly, the set screw block 156, connector elements 154A-C,insulative spacers 170A-E, and proximal connector portion 148 can bealigned, and the boot 162 can be applied to an exterior of the alignedassembly. For example, in one embodiment, the boot 162 can beconstructed of liquid silicone rubber, over-molded over the set screwblock 156, connector elements 154A-C, insulative spacers 170A-E and aportion of the proximal connector portion 148 extending therefrom.

The plurality of electrical conductors 164A-D can be positioned on theproximal portion 148. For example, in one embodiment, the adapter 106can include four electrical conductors 164A-D configured to electricallycouple to the corresponding electrical terminals of a neurostimulatordevice 102. For example, in some embodiments, the proximal portion 148of the adapter 106 can be configured to be received within a headerportion of the neurostimulator device 102 (as depicted in FIG. 3B). Theelectrical conductors 164A-D can be in electrical communication with theconnector elements 154A/C and/or set screw block 156 via one or morewires, cables or other connecting elements. In some embodiments, aportion of the boot 162 located between the electrical conductors 164and the connector elements 154 can be flexible, so as to enable bendingof the adapter 106 to aid in an ideal positioning of the neurostimulatordevice 102 relative to the stimulation lead 104 within the body of apatient.

Accordingly, in some embodiments, the adapter 106 can be configured toestablish a compatible electrical connection between a neurostimulatordevice 102 (which may be a replacement for a previously implantedneurostimulator device) and an implantable stimulation lead 104 (whichmay have been previously implanted into the patient). For example, inone embodiment, the neuromodulation adapter 106 can be configured toelectrically connect a previously implanted stimulation lead 104 havinga plurality of electrical connectors 116 spaced apart from one anotherat a first pitch with a replacement neurostimulator device 102 generallyconfigured to mate with a stimulation lead 104 having a plurality ofelectrical connectors 116 spaced apart from one another at a secondpitch. In embodiments, the first pitch can be approximately 0.170inches, and the second pitch can be approximately 0.085 inches. Further,in some embodiments, the adapter 106 can be magnetic resonance imaging(MRI) compatible.

FIG. 7A-B depict a second embodiment of a neuromodulation adapter 106′in accordance with the disclosure. In one embodiment, the adapter 106′can additionally include a chassis 152, into which the set screw block156, connector elements 154A-C, insulative spacers 170A-C can beassembled, prior to overmolding of the boot 162. Additionally, in someembodiments, the adapter 106 can include a septum 160 configured toprovide a fluid resistant seal to inhibit contact between the set screw158 and bodily fluid. In some embodiments, the boot 162 can extendoutwardly, so as to form a mound or hump surrounding the septum 160.

Other embodiments of neuromodulation adapter 106′, 106″ and 106′″ aredepicted in FIGS. 8-10. As shown in the figures, embodiments of theadapter 106 can, for example, include four connector elements 154A-D andan inactive set screw block 156 (as depicted in FIG. 8), three connectorelements 154A-C and an active set screw block 156 (as depicted in FIG.9), or four connector elements 54A-D (as depicted in FIG. 10). Otherconnector elements/set screw block configurations are also contemplated.As depicted in FIG. 9, where the set screw block is active, the adapter106 can include a fluid resistant barrier 160.

FIG. 11A depicts a previously implanted neurostimulator device 101 andstimulation lead 104, wherein the proximal portion 114 of thestimulation lead 104 includes connectors 116 having a pitch spacingabout 0.085 inches. FIG. 11B depicts a replacement neurostimulatordevice 102 configured to mate with a stimulation lead having a pitchspacing of about 0.170 inches. As further depicted in FIG. 11B, anadapter 206 can be used between the stimulation lead 104 and thereplacement device 102, thereby providing an electrical coupling betweenan otherwise incompatible stimulation lead 104 and neurostimulatordevice 102.

With additional reference to FIGS. 12A-C, similar to adapter 106,adapter 206 can include a plurality of connector elements 154A-D, setscrew block 156, set screw 158, boot 162, and a plurality of electricalconductors 164A-D. As depicted in FIGS. 12B-C, a plan view of theproximal portion 148 and the distal portion 150 are shown depictingexample dimensional spacing of the various components, in accordancewith one embodiment of the disclosure. FIG. 13 depicts anotherembodiment of adapter 206′, in accordance with the disclosure.Accordingly, in some embodiments, the adapter 206 can be configured toestablish a compatible electrical connection of a neurostimulator device102 generally configured to mate with a stimulation lead 104 having aplurality of electrical connectors 116 spaced apart from one another ata pitch of approximately 0.170 inches (which may be a replacement for apreviously implanted neurostimulator device 101), with an implantablestimulation lead 104 having a plurality of electrical connectors 116spaced apart from one another at a pitch of approximately 0.085 inches(which may have been previously implanted into the patient).

FIG. 14A depicts a previously implanted neurostimulator device 101 andstimulation lead 104, wherein the proximal portion 114 of thestimulation lead 104 includes connectors 116 having a pitch spacingabout 0.170 inches. FIG. 14B depicts a replacement neurostimulatordevice 102 configured to mate with a stimulation lead having a pitchspacing of about 2 mm (0.080 inches). As further depicted in FIG. 14B,an adapter 306 can be used between the stimulation lead 104 and thereplacement device 102, thereby providing an electrical coupling betweenan otherwise incompatible stimulation lead 104 and neurostimulatordevice 102. Accordingly, in some embodiments, the adapter 306 can beconfigured to establish a compatible electrical connection of aneurostimulator device 102 generally configured to mate with astimulation lead 104 having a plurality of electrical connectors 116spaced apart from one another at a pitch of approximately 2 mm (whichmay be a replacement for a previously implanted neurostimulator device101), with an implantable stimulation lead 104 having a plurality ofelectrical connectors 116 spaced apart from one another at a pitch ofapproximately 0.170 inches (which may have been previously implantedinto the patient).

FIG. 15A depicts a previously implanted neurostimulator device 101 andstimulation lead 104, wherein the proximal portion 114 of thestimulation lead 104 includes connectors 116 having a pitch spacingabout 2 mm (0.080 inches). FIG. 15B depicts a replacementneurostimulator device 102 configured to mate with a stimulation leadhaving a pitch spacing of about 0.170 inches. As further depicted inFIG. 15B, an adapter 406 can be used between the stimulation lead 104and the replacement device 102, thereby providing an electrical couplingbetween an otherwise incompatible stimulation lead 104 andneurostimulator device 102. Accordingly, in some embodiments, theadapter 406 can be configured to establish a compatible electricalconnection of a neurostimulator device 102 generally configured to matewith a stimulation lead 104 having a plurality of electrical connectors116 spaced apart from one another at a pitch of approximately 0.170inches (which may be a replacement for a previously implantedneurostimulator device 101), with an implantable stimulation lead 104having a plurality of electrical connectors 116 spaced apart from oneanother at a pitch of approximately 2 mm (which may have been previouslyimplanted into the patient).

FIG. 16A depicts a previously implanted neurostimulator device 101 andstimulation lead 104, wherein the proximal portion 114 of thestimulation lead 104 includes connectors 116 having a pitch spacingabout 2 mm (0.080 inches). FIG. 16B depicts a replacementneurostimulator device 102 configured to mate with a stimulation leadhaving a pitch spacing of about 0.085 inches. As further depicted inFIG. 16B, an adapter 506 can be used between the stimulation lead 104and the replacement device 102, thereby providing an electrical couplingbetween an otherwise incompatible stimulation lead 104 andneurostimulator device 102. Accordingly, in some embodiments, theadapter 506 can be configured to establish a compatible electricalconnection of a neurostimulator device 102 generally configured to matewith a stimulation lead 104 having a plurality of electrical connectors116 spaced apart from one another at a pitch of approximately 0.085inches (which may be a replacement for a previously implantedneurostimulator device 101), with an implantable stimulation lead 104having a plurality of electrical connectors 116 spaced apart from oneanother at a pitch of approximately 2 mm (which may have been previouslyimplanted into the patient).

FIG. 17A depicts a previously implanted neurostimulator device 101 andstimulation lead 104, wherein the proximal portion 114 of thestimulation lead 104 includes connectors 116 having a pitch spacingabout 0.085 inches. FIG. 17B depicts a replacement neurostimulatordevice 102 configured to mate with a stimulation lead having a pitchspacing of about 2 mm (0.080 inches). As further depicted in FIG. 17B,an adapter 606 can be used between the stimulation lead 104 and thereplacement device 102, thereby providing an electrical coupling betweenan otherwise incompatible stimulation lead 104 and neurostimulatordevice 102. Accordingly, in some embodiments, the adapter 606 can beconfigured to establish a compatible electrical connection of aneurostimulator device 102 generally configured to mate with astimulation lead 104 having a plurality of electrical connectors 116spaced apart from one another at a pitch of approximately 2 mm (whichmay be a replacement for a previously implanted neurostimulator device101), with an implantable stimulation lead 104 having a plurality ofelectrical connectors 116 spaced apart from one another at a pitch ofapproximately 0.085 inches (which may have been previously implantedinto the patient).

Further Examples

16. A neuromodulation adaptor configured to provide an electricalcoupling between an otherwise incompatible stimulation lead andneurostimulator device, the neuromodulation adaptor comprising:

a proximal portion including a plurality of electrical conductors spacedapart at a pitch spacing of approximately 0.170 inches and configured toelectrically engage with a corresponding plurality of electricalterminals of a neurostimulator device; and

a distal portion including plurality of conductor elements and a setscrew, the plurality of conductor elements spaced apart at a pitchspacing of approximately 2 millimeters and configured to electricallyengage with a corresponding plurality of electrical connectors of astimulation lead.

17. The neuromodulation adaptor of example 16, wherein the proximalportion includes a forward stop configured to serve as a reference pointfor spacing of the plurality of electrical conductors relative to acorresponding plurality of electrical terminals of a neurostimulatordevice.

18. The neuromodulation adaptor of example 16, wherein the distalportion includes an abutting surface configured to serve as a referencepoint for spacing of the plurality of conductor elements relative to acorresponding plurality of electrical connectors of a stimulation lead.

19. The neuromodulation adaptor of example 16, further comprising aflexible portion located between the proximal portion and the distalportion, configured to enable bending of the neuromodulation adaptor toaid in an ideal positioning of a neurostimulator device relative to astimulation lead within a body of a patient.

20. A neuromodulation adaptor configured to provide an electricalcoupling between an otherwise incompatible stimulation lead andneurostimulator device, the neuromodulation adaptor comprising:

a proximal portion including a plurality of electrical conductors spacedapart at a pitch spacing of approximately 0.085 inches and configured toelectrically engage with a corresponding plurality of electricalterminals of a neurostimulator device; and

a distal portion including plurality of conductor elements and a setscrew, the plurality of conductor elements spaced apart at a pitchspacing of approximately 2 millimeters and configured to electricallyengage with a corresponding plurality of electrical connectors of astimulation lead.

21. The neuromodulation adaptor of example 20, wherein the proximalportion includes a forward stop configured to serve as a reference pointfor spacing of the plurality of electrical conductors relative to acorresponding plurality of electrical terminals of a neurostimulatordevice.

22. The neuromodulation adaptor of example 20, wherein the distalportion includes an abutting surface configured to serve as a referencepoint for spacing of the plurality of conductor elements relative to acorresponding plurality of electrical connectors of a stimulation lead.

23. The neuromodulation adaptor of example 20, further comprising aflexible portion located between the proximal portion and the distalportion, configured to enable bending of the neuromodulation adaptor toaid in an ideal positioning of a neurostimulator device relative to astimulation lead within a body of a patient.

24. A neuromodulation adaptor configured to provide an electricalcoupling between an otherwise incompatible stimulation lead andneurostimulator device, the neuromodulation adaptor comprising:

a proximal portion including a plurality of electrical conductors spacedapart at a pitch spacing of approximately 2 millimeters and configuredto electrically engage with a corresponding plurality of electricalterminals of a neurostimulator device; and

a distal portion including plurality of conductor elements and anelectrically active set screw, the plurality of conductor elements and aset screw spaced apart at a pitch spacing of approximately 0.085 inchesand configured to electrically engage with a corresponding plurality ofelectrical connectors of a stimulation lead.

25. The neuromodulation adaptor of example 24, wherein the proximalportion includes a forward stop configured to serve as a reference pointfor spacing of the plurality of electrical conductors relative to acorresponding plurality of electrical terminals of a neurostimulatordevice.

26. The neuromodulation adaptor of example 24, wherein the distalportion includes a datum reference configured to serve as a referencepoint for spacing of the plurality of conductor elements relative to acorresponding plurality of electrical connectors of a stimulation lead.

27. The neuromodulation adaptor of example 24, further comprising aflexible portion located between the proximal portion and the distalportion, configured to enable bending of the neuromodulation adaptor toaid in an ideal positioning of a neurostimulator device relative to astimulation lead within a body of a patient.

28. The neuromodulation adaptor of example 24, further comprising aseptum configured to provide a fluid resistant seal to inhibit contactbetween the set screw and a bodily fluid.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPGAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor” as used herein may refer toany of the foregoing structure or any other physical structure suitablefor implementation of the described techniques. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

What is claimed is:
 1. A neuromodulation adaptor configured to providean electrical coupling between an otherwise incompatible stimulationlead and neurostimulator device, the neuromodulation adaptor comprising:a proximal portion including a plurality of electrical conductors spacedapart at a pitch spacing of approximately 0.085 inches and configured toelectrically engage with a corresponding plurality of electricalterminals of a neurostimulator device; and a distal portion includingplurality of conductor elements and an electrically active set screw,the plurality of conductor elements and electrically active set screwspaced apart at a pitch spacing of approximately 0.170 inches andconfigured to electrically engage with a corresponding plurality ofelectrical connectors of a stimulation lead.
 2. The neuromodulationadaptor of claim 1, wherein the proximal portion includes a forward stopconfigured to serve as a reference point for spacing of the plurality ofelectrical conductors relative to a corresponding plurality ofelectrical terminals of a neurostimulator device.
 3. The neuromodulationadaptor of claim 1, wherein the distal portion includes a datumreference configured to serve as a reference point for spacing of theplurality of conductor elements relative to a corresponding plurality ofelectrical connectors of a stimulation lead.
 4. The neuromodulationadaptor of claim 1, further comprising a flexible portion locatedbetween the proximal portion and the distal portion, configured toenable bending of the neuromodulation adaptor to aid in an idealpositioning of a neurostimulator device relative to a stimulation leadwithin a body of a patient.
 5. The neuromodulation adaptor of claim 1,further comprising a septum configured to provide a fluid resistant sealto inhibit contact between the electrically active set screw and abodily fluid.
 6. A neuromodulation adaptor configured to provide anelectrical coupling between an otherwise incompatible stimulation leadand neurostimulator device, the neuromodulation adaptor comprising: aproximal portion including a plurality of electrical conductors spacedapart at a pitch spacing of approximately 0.170 inches and configured toelectrically engage with a corresponding plurality of electricalterminals of a neurostimulator device; and a distal portion includingplurality of conductor elements and a set screw, the plurality ofconductor elements and a set screw spaced apart at a pitch spacing ofapproximately 0.085 inches and configured to electrically engage with acorresponding plurality of electrical connectors of a stimulation lead.7. The neuromodulation adaptor of claim 6, wherein the proximal portionincludes a forward stop configured to serve as a reference point forspacing of the plurality of electrical conductors relative to acorresponding plurality of electrical terminals of a neurostimulatordevice.
 8. The neuromodulation adaptor of claim 6, wherein the distalportion includes a datum reference configured to serve as a referencepoint for spacing of the plurality of conductor elements relative to acorresponding plurality of electrical connectors of a stimulation lead.9. The neuromodulation adaptor of claim 6, further comprising a flexibleportion located between the proximal portion and the distal portion,configured to enable bending of the neuromodulation adaptor to aid in anideal positioning of a neurostimulator device relative to a stimulationlead within a body of a patient.
 10. The neuromodulation adaptor ofclaim 6, further comprising a septum configured to provide a fluidresistant seal to inhibit contact between the set screw and a bodilyfluid.
 11. A neuromodulation adaptor configured to provide an electricalcoupling between an otherwise incompatible stimulation lead andneurostimulator device, the neuromodulation adaptor comprising: aproximal portion including a plurality of electrical conductors spacedapart at a pitch spacing of approximately 2 millimeters and configuredto electrically engage with a corresponding plurality of electricalterminals of a neurostimulator device; and a distal portion includingplurality of conductor elements and an electrically active set screw,the plurality of conductor elements and a set screw spaced apart at apitch spacing of approximately 0.170 inches and configured toelectrically engage with a corresponding plurality of electricalconnectors of a stimulation lead.
 12. The neuromodulation adaptor ofclaim 11, wherein the proximal portion includes a forward stopconfigured to serve as a reference point for spacing of the plurality ofelectrical conductors relative to a corresponding plurality ofelectrical terminals of a neurostimulator device.
 13. Theneuromodulation adaptor of claim 11, wherein the distal portion includesa datum reference configured to serve as a reference point for spacingof the plurality of conductor elements relative to a correspondingplurality of electrical connectors of a stimulation lead.
 14. Theneuromodulation adaptor of claim 11, further comprising a flexibleportion located between the proximal portion and the distal portion,configured to enable bending of the neuromodulation adaptor to aid in anideal positioning of a neurostimulator device relative to a stimulationlead within a body of a patient.
 15. The neuromodulation adaptor ofclaim 11, further comprising a septum configured to provide a fluidresistant seal to inhibit contact between the electrically active setscrew and a bodily fluid.